Patient Education for Increasing Clinical Trial Offers and Participation among Black and Indigenous People of Color (BIPOC) Populations with Cancer, DISRUPT Trial

PRIMARY OBJECTIVES:

I. To establish Action-Research Partnerships with up to 12 community organizations to implement the tailored strategies to initiate dialogue about cancer research with the 12 community organization’s constituents and networks (Aim 1).

II. To conduct a community-wide Annual Assessment of Norms regarding clinical trials (Aim 1).

III. To increase both accruals to clinical trials overall and of black and indigenous people of color (BIPOC) populations (Aim 2).

SECONDARY OBJECTIVES:

I. To conduct qualitative research in up to 16 Community Studios to evaluate community stakeholders’ attitudes and beliefs about cancer clinical trials and related issues (Aim 1).

II. To utilize the qualitative data from community studios to tailor messages and outreach approaches that are responsive to community concerns about clinical trials (Aim 2).

III. To design a quantitative, community-wide Annual Assessment of Norms regarding clinical trials (Aim 2).

IV. To create an electronic approach to identify key clinical characteristics of patients and trials and match patients and trials. (Aim 2)

V. To design an implementation strategy to maximize uptake and sustainability in a variety of clinical settings (Aim 2).

OUTLINE:

AIM 1: Participants participate in a "community studio" over 2 hours either in-person or via video. Community groups will participate in research action designing and disseminating messages to the community about clinical trials. Annual surveys will be done to assess penetration of messaging into communities.

AIM 2:

KEY INFORMANT INTERVIEWS: Oncologists, members of the medical and research teams, clinical trials office staff, and cancer center and information technology (IT) leaders will undergo an hour-long interview.

FOCUS GROUPS OR INTERVIEWS: Patients with cancer undergoing active treatment and cancer survivors will participate in a focus group or interview to address challenges and opportunities for clinical trials accrual.

Participants are assigned to 1 of 2 arms in Aim 2.

ARM 1: CLINICAL TRIAL MATCH-LIST INTERVENTION (PATIENTS): Patients with breast, lung or liver cancer view an informational sheet and educational materials (written or video) before or after the first visit with their doctor. If matched with any trials, patients will be provided a list of clinical trials for which they may be eligible. Patients will also complete a survey prior to and after the intervention.

ARM 2: CLINICAL TRIAL MATCH-LIST INTERVENTION (PHYSICIANS): Physicians are provided with a matched list of clinical trials to discuss with their patients, if relevant. Physicians will also complete a survey prior to and after the intervention.

After completion of the Aim 2 match-list intervention, patients are will be surveyed. Participating physicians are surveyed prior to and 6 months after the intervention implementation.